This clinical trial compares the effects of four smoking cessation interventions on smoking cessation and abstinence in underserved patients referred for lung cancer screening. While lung cancer screening reduces death and disease among current and former smokers at risk for cancer and increases their access to care, few studies have examined cessation strategies among underserved populations. This clinical trial compares the effects of different combinations of the Ask-Advise-Refer intervention, nicotine replacement therapy and cessation aids, financial incentives, and a mobile health application intervention on smoking behaviors in underserved populations.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04798664.
PRIMARY OBJECTIVES:
I. Compare the effectiveness of the two main interventions currently used to promote smoking cessation in the context of lung cancer screening:
a. Ask-Advise-Refer.
b. Ask-Advise-Refer plus free access to nicotine replacement therapy and Food and Drug Administration (FDA)-approved pharmacologic cessation aids.
II. Compare these standard approaches with multicomponent interventions that add one or both of:
a. Financial incentives for successfully quitting.
b. Financial incentives plus a mobile health application that motivates patients to think about their future health through episodic future thinking.
III. Assess heterogeneity in the effectiveness of these four interventions in promoting cessation among smokers that differ by race, ethnicity, income, education, rurality, tobacco dependence, and objectively reported and patient-perceived lung cancer screening results.
OUTLINE: Participants are randomized to 1 of 4 arms. Participants without a cell phone are randomized to arms 1, 2, or 3.
ARM I: Participants receive the usual care approach of Ask-Advise-Refer.
ARM II: Participants receive the usual care approach of Ask-Advise-Refer and are provided access to pharmacotherapy and nicotine replacement patches, gum, or lozenges.
ARM III: Participants receive the usual care approach of Ask-Advise-Refer, are provided access to pharmacotherapy and nicotine replacement patches, gum, or lozenges, and receive cash incentives for nicotine abstinence.
ARM IV: Participants receive the usual care approach of Ask-Advise-Refer, are provided access to pharmacotherapy and nicotine replacement patches, gum, or lozenges, receive cash incentives, and receive a mobile health application intervention.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorScott David Halpern
